Pharmaceutical Compositions Comprising Effervescent Agents and Fenofibrate

Abstract

A pharmaceutical composition comprising at least one effervescent agent and a fibrate and a process for making such composition. The fibrate is fenofibrate and the effervescent agent are in a dosage form. The dosage form increases dissolution and absorption of fenofibrate in biological conditions where the form contacts acidic gastric fluid after oral administration.

1 . A pharmaceutical composition comprising an effervescent agent and a fibrate. 
   
   
       2 . The composition of  claim 1  wherein the fibrate is fenofibrate. 
   
   
       3 . The composition of  claim 1  further comprising pharmaceutical excipients. 
   
   
       4 . The composition of  claim 2  wherein the effervescent agent is a carbonate. 
   
   
       5 . The composition of  claim 4  wherein said carbonate is selected from the group consisting of sodium carbonate, sodium bicarbonate, potassium carbonate, potassium bicarbonate, sodium sesquicarbonate, sodium glycine carbonate, L-lysine carbonate, arginine carbonate and calcium carbonate. 
   
   
       6 . The composition of  claim 3  wherein the pharmaceutical excipients are selected from the group consisting of disintegrants, fillers, lubricants and antiadherents. 
   
   
       7 . A process for making the composition of  claim 2  wherein said process is selected from the group consisting of a mixing process, a granulation process, a coating process and a melt-congealing process. 
   
   
       8 . The process of  claim 7  wherein the melt-congealing process comprises the steps of:
 incorporating the effervescent agent and other excipients into molten fenofibrate; and   forming a solid dispersion of the effervescent agent and other excipients in fenofibrate that is suitable for manufacturing a finished dosage form.   
   
   
       9 . The process of  claim 7  wherein the step of forming a solid dispersion is a rotary atomization process, an extrusion process or a milling process. 
   
   
       10 . The process of  claim 7  further comprising the step of preparing a finished dosage form. 
   
   
       11 . The process of  claim 10  wherein the finished dosage form is a tablet. 
   
   
       12 . The process of  claim 10  wherein the finished dosage form is a capsule. 
   
   
       13 . A method for lowering lipids comprising the administration to a patient in need of such treatment of an effective amount of the pharmaceutical composition of  claim 2 . 
   
   
       14 . A method for lowering lipids comprising the administration to a patient in need of such treatment of an effective amount of the pharmaceutical composition prepared by the process of  claim 7 .